New EFSA guidance on Dermal absorption - Implementation dates in the UK

Regulatory Update: 27/2012

Issued: 1 August 2012

Applicants and test facilities should be aware that the Standing Committee on the Food Chain and Animal Health has formally noted the EFSA guidance document on Dermal Absorption (see http://www.efsa.europa.eu/en/efsajournal/pub/2665.htm ).

Significant aspects of the new EFSA guidance include:

• Revised (lower) default values of 75% or 25%;
• Defined criteria for many aspects of dermal absorption, intended to improve consistency of interpretation e.g. for extrapolating data between products and on approaches to the use of tape stripping data;
• Support for dermal absorption values based on in vitro data alone.”

The agreement at the Standing Committee (of May 2012) was that the new guidance will apply to all applications received after 30th November 2012.

However, CRD believes that the concepts set out in the guidance document are helpful and will apply it to all ongoing and future plant protection product applications. In particular the majority of the text in the EFSA guidance document provides clarification and defined criteria for existing CRD approaches to dermal absorption. We also note that OECD guidance document 156 on dermal absorption was published in August 2011 and is broadly similar to the EFSA guidance in many areas and that the EFSA guidance provides for applicants to present a reasoned case if they consider the guidance document criteria do not match a particular product’s characteristics.